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SOP of Stability Study - 2

This document outlines procedures for conducting additional stability studies on drug products under various stress conditions, including elevated temperatures, light, and humidity. Samples would be observed regularly and tested monthly to assess physical and chemical changes over periods of 1-3 months. Additional studies may be required under different storage conditions or due to changes in manufacturing process or materials. Bracketing and reduced testing is allowed when multiple products have identical formulations and packaging.

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173 views

SOP of Stability Study - 2

This document outlines procedures for conducting additional stability studies on drug products under various stress conditions, including elevated temperatures, light, and humidity. Samples would be observed regularly and tested monthly to assess physical and chemical changes over periods of 1-3 months. Additional studies may be required under different storage conditions or due to changes in manufacturing process or materials. Bracketing and reduced testing is allowed when multiple products have identical formulations and packaging.

Uploaded by

Yousif
Copyright
© © All Rights Reserved
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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5.

4 ADDITIONAL NEED-BASED STABILITY STUDIES

5.4.1 Stress Testing

5.4.1.1 Additional stability studies under stress conditions shall be done (if required) to check
the stability of the drug products.

5.4.1.2 The following conditions are suggested for stress testing of drug products:

a. Increments of 5°C or 10°C higher than accelerated temperature of 40°C to cover the
studies of influence of dry heat on drug products. This test is to simulate hot conditions
faced by drug products during transportation and shipment.

b. Simultaneous exposure to 40°C and a minimum of 1.2 million lux h fluorescent light and
200W h/m2 UV light. This test is meant to study the influence of tropical conditions on
the drug products.

c. Any other storage conditions specified by regulatory authorities or any tie up companies.

5.4.1.3 The stress testing shall be done on a single and initial batch of a product, which must
be of the same formulation and quality as the marketing product, including the
packaging.

5.4.1.4 The stress testing shall be conducted at the time interval of 1 month, 2 months and 3
months.

5.4.1.5 The samples shall be observed for physical/ chemical changes at a regular interval of
about 15 days and sampling shall be done on monthly basis.

5.4.2 Additional stability studies shall be done in case (but not limited) of major deviation in
process, new equipments, new sources of raw material and/or change in primary packing
material but depth of studies like no. of batches, storage condition(s) shall be decided
based on risk assessment.
5.4.3 Additional stability studies shall carried out for the same batches kept for regular
stability studies beyond the stipulated time intervals / conditions as per the directives
received from Tie Up Company or location Quality – Head or his designate.

5.4.4 Additional stability studies shall be carried out as per the customer’s requirement based
on the storage conditions and the frequencies of analysis as given by the customer.

5.4.5 Additional stability studies shall be carried out as per the directions received from
“Change Control Committee”

5.4.6 Additional stability studies shall be carried out as per requirement of Tie Up Company
or direction of Regulatory agencies(s) at any other specified temperature and RH
conditions.

5.5 SAMPLING

5.5.1 The IPQA(In-process Quality Assurance) personnel shall collect the product samples
for  stability studies from optimisation and validation batches and subsequently minimum
one batch (preferably first batch of the year) per year including all different packing like
blisters, strips and/or containers etc shall be considered.

5.5.2 QA department shall inform the warehouse in-charge for stability plan with product
name, batch number and sample quantity. IPQA personnel shall collect the stability
sample from warehouse.

5.5.3 QA department shall label the stability samples individually with colored labels
specified as per Labelling Policy.

5.5.4 QA department shall put the samples at different storage conditions in stability
chambers and maintain the storage record on  Finished Product Stability Sample Storage
Record (Appendix I).
5.5.5 Withdraw the samples as per the schedule and maintain the record on Accelerated
Stability Withdrawal Record (Appendix II) and  Long Term Stability Withdrawal Record
(Appendix III)

5.6 Bracketing of product

5.6.1 In case the product has identical formulation but there are different packing
configurations with same primary packing material, then any one type of packing
configuration shall be chosen and samples shall be collected.

5.6.2 If product is manufactured under different brand names but the formulation, strength
and manufacturing process remains same with same primary packing materials then
samples of any one brand name shall be collected.

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